Lipocine Inc.
- Market Cap (Float-Adj) (Float-adjusted market cap computed by the low-float screener — matches the screener row. May differ from the standard cap (price × all shares outstanding) reported elsewhere.)
- $17.3M
- Price
- $2.10
- % Change (Daily % change from the live per-ticker quote feed.)
- +1.45%
- Volume
- 12.8K
About
Lipocine Inc. is a biopharmaceutical firm currently in the clinical development phase, concentrating its efforts on creating medicinal products to address a range of neuroendocrine and metabolic conditions. A core aspect of the company's research and development involves formulating oral delivery methods for pharmaceutical compounds that typically suffer from low bioavailability. Its foremost investigational therapy is TLANDO, an oral solution for testosterone replacement. The company's development pipeline also encompasses several other promising candidates: LPCN 1144: An orally administered prodrug derived from bioidentical testosterone, which has successfully completed Phase II clinical trials for the treatment of non-cirrhotic non-alcoholic steatohepatitis. LPCN 1111: An oral prodrug of testosterone tridecanoate, engineered for once-daily administration, and having also concluded Phase II clinical studies in men experiencing hypogonadism. LPCN 1148: A novel prodrug combining testosterone and testosterone laurate, designed for the management of decompensated cirrhosis. LPCN 1154: An investigational new drug application has been submitted to initiate a Phase 2 study targeting Postpartum Depression. LPCN 2101: A compound intended for women with epilepsy, which has progressed beyond its pre-clinical study phase. LPCN 1107: An oral hydroxyprogesterone caproate product, which has completed its dose-finding Phase II clinical trial aimed at preventing recurrent preterm birth. The corporate headquarters for Lipocine Inc. are located in Salt Lake City, Utah.
Quick stats
Shares outstanding8.2M
Computed float7.5M
Float / shares91.3%
Key info
SectorHealthcare
IndustryBiotechnology
CIK (Central Index Key — the unique ID the SEC assigns to every filer. Use it to look up the company's filings on EDGAR.)0001535955
Websitehttps://www.lipocine.com
AI Summary
AI-generated1/9
standardmixedclinical trial
Lipocine Announces Initiation of BLOOM Phase 3 Study of LPCN 1154 for Postpartum Depression
Lipocine initiated BLOOM, a Phase 3 study of LPCN 1154 (oral brexanolone) for postpartum depression, planning approximately 120 participants with first dosing expected in early Q4 2026 as a 48-hour at-home oral regimen.
The study is a retry after the prior Phase 3 missed its primary endpoint; exploratory analyses excluding one high-enrolling site — where roughly 40% of treated participants had no detectable study drug in blood — suggested rapid and sustained improvement, which the company explicitly calls non-confirmatory.
Prior-trial safety was clean, with no treatment-related severe or serious adverse events, no excessive sedation and no discontinuations, and BLOOM adds strengthened site and data-quality controls plus placebo-response countermeasures to support a potential 505(b)(2) NDA.
Lipocine reported $23.3 million in unrestricted cash and investments as of June 30, 2026 with expected average cash use of about $1 million per month during the study; existing resources are said to fund BLOOM but not regulatory approval or commercialization, pointing to eventual financing or partnership needs.
Red flags
- Prior Phase 3 missed its primary endpoint; the new pivotal study is based on exploratory post hoc site-exclusion analyses the company itself labels non-confirmatory
- Company states existing resources will not fund regulatory approval or commercialization — future dilution or partnership likely
- Cash of $23.3M against ~$1M/month planned burn implies under two years of runway before other operating needs
- LPCN 1154 is not FDA-approved and no head-to-head data establish superiority over approved PPD treatments such as ZURZUVAE